Xodus Medical Inc
New Kensington, PA, US
XODUS MEDICAL, INC. appears in FDA device records in New Kensington, PA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Xodus Medical Inc between 2006 and 2026. The busiest year on record is 2006, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2018 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260903 | Hot Pink Pad Warming System | DWJ | Substantially Equivalent | |
| K182080 | Scope Antifogging System | GCJ | Substantially Equivalent | |
| K081647 | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS | GEI | Substantially Equivalent | |
| K063587 | XODUS MEDICAL ANTI-FOG SOLUTION | OCT | Substantially Equivalent | |
| K053433 | CAUTERY TIP CLEANER, MODEL 30500 | GEI | Substantially Equivalent | |
| K053321 | LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER | FTA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2530138 | 1000221205 | XODUS MEDICAL, INC. | 702 PROMINENCE DR., New Kensington, PA 15068 US | 2026 | and 20 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- OCTAnti Fog Solution And Accessories, Endoscopy
- FQMBandage, Elastic
- FNYBasin, Emesis
- GESBlade, Scalpel
- JOLCatheter And Tip, Suction
- KQZComponent, Traction, Non-Invasive
- KYWContainer, Liquid Medication, Graduated
- FMRDevice, Transfer, Patient, Manual
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- FRLFiber, Medical, Absorbent
- GDYGauze/Sponge, Internal, X-Ray Detectable
- GDZHandle, Scalpel
- MDMInstrument, Manual, Surgical, General Use
- KDDKit, Surgical Instrument, Disposable
- LYVLabel Or Tag, Sterile
- GCJLaparoscope, General & Plastic Surgery
- FTALight, Surgical, Accessories
- FZZMarker, Skin
- GABNeedle, Suturing, Disposable
- OEANon-Surgical Gown
- FWZOperating Room Accessories Table Tray
- FQAScale, Surgical Sponge
- FPPStretcher, Hand-Carried
- CCXSupport, Patient Position
- KYZSyringe, Irrigating (Non Dental)
- DWJSystem, Thermal Regulating
- KGXTape And Bandage, Adhesive
- FTYTape, Measuring, Rulers And Calipers
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0151-2020 | Cautery Tip Cleaner REF: 30500 Product Usage: electrosurgical accessory | The sterile barrier of some devices may have been affected | Class II | Terminated | |
| Z-0150-2020 | Electrosurgical Tip Cleaner REF: 62-8499-001 Product Usage: electrosurgical accessory | The sterile barrier of some devices may have been affected | Class II | Terminated | |
| Z-0149-2020 | Electrosurgical Tip Cleaner REF: 138029 Product Usage: electrosurgical accessory | The sterile barrier of some devices may have been affected | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain